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Functional Foods:

Food Product Design

Functional Foods:
Figuring Out the Facts

November 1999 -- Cover Story

By: Andrea Platzman, R.D.
Contributing Editor

  The link between diet and health is thousands of years old, with Chinese medicine recognizing the connection as early as 1000 B.C. This link has taken center stage in recent years, however, with the emergence of what's come to be known as "functional foods." Since expanding to mainstream supermarket shelves from health-food stores, functional foods have reached $17 billion in annual global sales, and this amount is increasing at a steady rate. According to IFT president-elect Mary K. Schmidl at the "Functional Foods: Strategies for the Food Industry" conference this past June in Newport Beach, CA, the estimated functional-foods market in the United States is over $200 billion - depending on the definition given to "functional."

  What exactly is a functional food? Unfortunately, the precise definition is not universal - it varies from country to country, or even from company to company, and it's still evolving. In addition, the category of functional foods also includes nutraceuticals, designer foods, pharmafoods and other similar classifications. A 1994 definition from the Washington, D.C.-based National Academy of Sciences' Institute of Medicine states: "Functional foods are foods that encompass potentially healthful products, including any modified food or food ingredient that may provide a health benefit beyond the traditional nutrients it contains."

  Such a definition is broad, and yet incomplete, in terms of encompassing products being developed under the functional-foods principle. A wide variety of foods, such as skim milk and low-sodium soup, would be part of such a definition. Other foods high in fiber, antioxidants and phytochemicals, such as dried fruit, might be excluded. Schmidl proposed this possible definition for functional foods in her address: "A conventional food with nutrient-content claims, pre-approved health claims, an authoritative statement such as the Food and Drug Administration Modernization Act, and structure-function claims with disclaimer or structure-function claims without disclaimer."

Functional foods origins
  Americans have been eating fortified foods since 1917, when manufacturers started adding iodine to salt to prevent the nutritional deficiency that causes goiter. But functional foods represent a new concept, i.e., treating or preventing symptoms and diseases, not simply deficiencies.

  In 1984, functional foods were first introduced in Japan when the Foods for Specified Health Use program, known as FOSHU, was developed by the Ministry of Health and Welfare. Given Japan's aging population, this represents an important step in reducing health-care costs. It's estimated that by 2025, 28% of the Japanese population will be over 65 years old, compared to an estimated 18% in the United States.

  FOSHU products are "foods which are expected to have certain health benefits that have been licensed to bear a label claiming that a person using them for specific health use may expect to obtain the health use through consumption thereof." There are two mandatory restrictions - products must be in common food form, and products must be consumed on a daily basis as part of a regular diet. In addition, it is recommended, though not required, that FOSHU products be competitively priced in comparison to non-FOSHU products. "This year, there are 149 approved, finished FOSHU products in Japan, mostly in the soft drink/beverage market," said Ron Bailey, president of California Functional Foods, Ashland, OR, at the 1999 Institute of Food Technologists (IFT) Annual Meeting and Food Expo®.

  With approximately 1.5 million Americans suffering from cardiovascular disease this past year, and over a million Americans inflicted with cancer, it is not surprising that over $15 billion per year is spent on alternative therapies. "People are trying to take an alternative route to medicine," said Mark Blumenthal, Ph.D., president of the American Botanical Council, Austin, TX, at the IFT conference. "People are motivated by the benefits of foods, as opposed to the avoidance of certain foods."

  The search for alternative therapies, rising health care costs, an aging population, advances in technology, and changes in government regulations are all fueling the functional-foods market boom in the United States. The International Food Information Council (IFIC), Washington D.C., conducts research on functional foods with consumers and health professionals. In a 1998 survey, nine out of 10 consumers believed they had control over their own health. In research conducted in March of the following year, the groups queried had both motivated and unmotivated participants. The unmotivated group was unaware of the diet and health connection, but would be open to consuming a beneficial component if added to a food they already eat. The motivated group readily absorbed, and believed in, the information about diet and health.

Regulatory perspective
  Since functional foods do not possess a legal definition, they do not have straightforward regulations. Are these foods dietary supplements, new drugs, or food additives? The government regulates each of these categories differently. New foods and drugs must always have FDA approval; in comparison, dietary supplements are lightly regulated.

  The Nutrition Labeling and Education Act (NLEA) of 1990 allows disease-prevention claims to be made for a food, but only after the food is in accordance with FDA regulations. The NLEA food-labeling regulations are extensive, and provide for a prominent panel of nutrition facts, daily reference values, ingredient declarations, and nutrient-content and health claims. Serving sizes are standardized, which provides a basis for comparison among products and claims. Health claims are defined and limited to a description of a relationship between a nutrient and a disease or health condition in terms of significance within the total diet. In addition, health claims require extensive scientific documentation, as well as FDA approval.

  In contrast, the Dietary Supplement Health Education Act (DSHEA) of 1994 defines dietary supplements as a product added to the total diet that contains at least one of the following: a vitamin, mineral, herb, botanical, amino acid, or any other dietary substance used to supplement the diet. Manufacturers do not need FDA approval prior to selling dietary supplements. However, as of March 1999, according to an addendum to DSHEA, manufacturers must provide a supplement facts label. This label is similar to the nutrition facts label, and provides the following information: statement of identity (i.e., ginseng); net quantity of contents (i.e., 60 capsules); structure-function claim with the words: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease."; directions for use (i.e., take one capsule daily); supplement facts panel (lists serving size, amount and active ingredients); other ingredients in descending order of dominance; and name and location of business or manufacturer.

  Where do functional foods fit? New conventional foods or color additives require FDA approval. Dietary supplements marketed in the United States prior to October 15, 1994 do not need FDA approval. Those marketed after this date require FDA notification 75 days prior to use, unless the ingredient has been present in the food supply as an article used for food in a form in which the food has not been chemically altered. Confused? Many manufactures are too. Currently, most functional foods do not fit neatly into any one category, and many are sold as dietary supplements. Health claims can be made for dietary supplements without prior FDA approval, as long as research exists to back up the claims. Four types of health-related claims can be made:

  • Nutrient-content claim - expresses characteristics of a food based on nutrient level. Examples: "low in sodium," "low in fat."
  • Health claim - characterizes the relationship of food to disease or condition. Example: "Dietary fiber may reduce the risk of certain cancers."
  • Structure-function claim - links a nutrient solely to the normal healthy function or structure of the body. Example: "Helps maintain normal cholesterol levels."
  • Special dietary usefulness claim - makes a product-based claim such as "hypoallergenic food."
  FDA pre-market approval, based on significant scientific safety and efficacy data, is required for a new nutrient-content claim or a new health claim, both for conventional foods and dietary supplements. A health or a nutrient-content claim that is based on public authoritative statements can be written 120 days prior to use without FDA approval. Recently, Minneapolis-based General Mills used this route for whole-grain foods. Structure-function claims may be used immediately, without FDA approval, although supporting data needs to be sent to the FDA, and a 30-day notification of first marketing of supplements needs to be filed. Foods for special dietary use require prior FDA approval, but medical foods do not need any prior approval or notification.

  A functional food can immediately be put onto store shelves, or it might take up to two years, depending on the regulatory route taken and the ingredient added. On July 1, 1999, a landmark court decision stated that the FDA cannot prevent companies from making health claims on labels because it violates free speech. However, false and misleading labeling information is not protected, and potentially misleading statements should be further explained with additional evidence or use of a disclaimer.

Top functional components
  Calcium. Attendees of the IFT conference may have noticed that globally, calcium won the award for the ingredient most frequently added to functional foods. This is not surprising, since according to the National Osteoporosis Foundation, Washington, D.C., 28 million people are affected by osteoporosis, and that number may increase to 41 million by 2015 as the U.S. population ages. With osteoporosis prompted by poor calcium intake beginning early in life, functional foods with calcium can be enjoyed, and are needed, across every population group.

  In addition to building a strong skeleton, calcium is essential for muscle function, hormone regulation and enzyme activation. Recent research has also found that calcium may reduce colon cancer in persons previously diagnosed with colon polyps and cancer. In 1997, the Institute of Medicine's Food and Nutrition Board updated and expanded its Recommended Dietary Allowances (RDAs) for calcium. For children ages 9 to 18, the recommendation is 1,300 mg per day, and for adults 51 and older, it is 1,200 mg per day. The tolerable upper intake level is now 2,500 mg per day. Unfortunately, the average adult in this country consumes between 500 and 700 mg of calcium daily, and young women between 12 and 19 years old consume only 777 mg per day.

  Part of the problem is that most children, as well as adults, replace milk with other beverages. In Japan, the average calcium intake is 573 mg per day, which has led to the introduction of many FOSHU products that contain calcium. Many of these are beverage-type products since, in Japan, the vending-beverage category is approximately $2.5 million, according to Bailey.

  Before adding calcium to existing products, product designers must consider a number of bioavailability, solubility and taste factors. "The absorption of calcium from foods or supplements is important, but the calcium's utilization at the bone level also needs to be considered," says Stacey Goebel, technical sales manager at Avonmore Waterford Ingredients, Inc., Monroe, WI. "The calcium-to-phosphorus ratio is an important factor in building bone density, with bone minerals needed for the development. The ratio of calcium to phosphorus found in milk and human bone is very similar to that found in our company's milk calcium, containing 26% calcium and 40% phosphorus," she continues.

  "The amount of calcium bioavailability depends on the calcium load or the status of the individual," says Barbara van Mossevelde, technical advisor, Purac America, Inc., Lincolnshire, IL. She explains that the more calcium in the diet, the lower the rate of its absorption. The general effective calcium absorption is about 30% for all calcium formulations. At stomach pH, all calcium preparations have approximately an 85% to 90% bioavailability. In the small intestine, which has a higher pH, calcium gluconate and tricalcium phosphate are only 40% bioavailable, and calcium phosphate and calcium carbonate are only 20% bioavailable.

  Solubility can be a problem when formulating beverages with calcium, since both calcium phosphate and calcium carbonate will precipitate. Calcium lactate has the highest solubility, at 9.3 grams of calcium per liter at 25°C, and is a good choice for use in beverages. Combining two salts can increase solubility; for example, a gluconate/lactate combination can yield a solubility of up to 45 grams per liter at 25°C.

  "Most calcium preparations are bland in taste and do not require any masking of the flavor in any application," says Goebel. However, high concentrations, particularly with insoluble forms, can form a chalky and gritty mouthfeel.

  "Adding a calcium preparation can work with any food, though some applications may require additional equipment," states Sarah Bugay, sales manager, pharmaceutical and food additives, Glucona America, Inc., Valhalla, NY. "Even iced tea, with its tannins, has been formulated with calcium. It is difficult, but it can be done."

  Herbs. An herb is defined as any plant or plant part used medicinally or for flavoring food. According to Blumenthal, at least 40% to 50% of Americans have used some herbal product in the past year. The herbal market is booming, with current annual sales reaching $4 billion.

  One third of all over-the-counter drugs in Germany are herbal medicines, and based on Germany's market-driven needs, this country is the leader in herbal studies. "Sometimes, all the studies on an herb are based on one company's product," explains Blumenthal. "Can other companies borrow that research for safety and efficacy when the extract, the dosage and the dosage forms are all different?"

  Standardization might not be the total answer, but it's an important first step. "Standardizing products is sometimes difficult to balance, since all the ingredients are natural and the quality can change," says David Wilson, president and CEO of A.M. Todd Botanicals (formerly Folexco/East Earth Herb), Montgomeryville, PA. "To ensure the quality of the herbs, we go from the farm to the pharmacy and test at every break in the supply chain. It is important to know your supplier, inspect your supplier's facility, and make sure that the supplier has quality control set up for pesticides and heavy metals, as well as technical support.

  "Using herbs in functional foods is not really an issue as long as the manufacturers do their homework and know which compounds work best together," continues Wilson. "When adding an herb into a high-pH system such as yogurt, the herb may lose its efficacy. Knowing which herbs complement which flavors, and also knowing which flavors mask certain herbs, is vital to the success of the product. For instance, after thorough research, we know that honey, cheese or maple flavors work well to mask St. John's wort."

  According to Maureen Draganchuk, vice president, business development, Virginia Dare, Brooklyn, NY, the flavor type must be compatible with the total concept, and must be complementary to the notes being introduced. If the base of the newly developed functional food has strong off-notes (bitter, green, beany, metallic, medicinal), working with flavor companies to minimize or mask these notes should come first, and then the appropriate characterizing flavor may be added. A tea profile can complement most herb profiles, while mint and vanilla can effectively cover bitter notes. Chocolate, coffee and grapefruit can complement bitter profiles, since their flavor profiles are expected to be slightly to moderately bitter. Juicy, sweet-berry flavors can cover astringency, but sour notes cannot be completely masked. Citrus and cranberry flavors can complement a sour-tasting additive.

  When adding herbs to a product, or formulating a new product with herbs, there's an ethical angle to consider. "Some products on the grocery shelves do not contain enough of the beneficial herb/phytochemical/dietary supplement to give any of the positive effects," according to Joseph Borzelleca, Ph.D., professor emeritus, Medical College of Virginia, at the "Functional Foods: Strategies for the Food Industry" conference. "It's important to remember that if you're going to take something, take it in a therapeutic dose. For example, the treatment of depression is 300 mg of St. John's wort - how much Hypericum perforatum is in each product?"

  "Current trends in the herbal market include kosher and organic certifications, food-grade GMPs (good manufacturing practices) and microbiological testing," states Wilson. At the "Functional Foods: Strategies for the Food Industry" conference, Theodore Labuza, Ph.D., a Morse distinguished teaching professor at the University of Minnesota, Minneapolis-St. Paul, reviewed the major GMP concerns for manufacturers of functional foods:

  • Filth from the growing and harvesting of herbs and botanicals (similar to that found in spices).
  • Identity of herbs and botanicals.
  • Lack of data on the effects of processing and storage on active metabolite x.
  • Analytical methods for active metabolite x.
  Currently, no regulations set standards for allowable amounts of pathogens and natural carcinogens in herbs and similar ingredients, but standards similar to our current standard food practices should be set.

  Fiber. Many studies suggest that daily consumption of fiber reduces the risk of chronic diseases, including cancer and cardiovascular disease. Recommended fiber intake is 25 to 35 grams of fiber each day, although most Americans consume about half that amount.

  There are two types of fiber - soluble and insoluble. Products in Battle Creek, MI-based Kellogg Company's new Ensemble line of functional foods (including frozen entrees, bread, dry pasta, ready-to-eat cereal, baked-potato crisps, frozen breakfast/dessert mini-loaves and cookies) contain psyllium, a type of soluble fiber. A study published in the American Journal of Clinical Nutrition found that one dose of psyllium fiber per day helped lower total cholesterol levels by 7% and LDL cholesterol by 15%. Oat bran (beta-glucan) and psyllium are the only two fibers allowed by the FDA to make claims related to cholesterol reduction and heart disease. However, numerous other soluble fibers could also potentially be used in functional foods.

  Nondigestible fibers, known as oligosaccharides, have been shown to benefit the host by selectively stimulating the activity of bacteria already in the colon. Used to cut calories and fat in food products, these fibers also reduce the risk of some chronic diseases by lowering blood triglyceride levels, increasing HDL cholesterol, increasing stool weight and frequency, controlling blood glucose, and possibly preventing colon cancer. Oligosaccharides such as inulin and oligofructose have been shown to improve the body's absorption of minerals such as calcium, magnesium and iron. Current applications include cereals and breakfast bars, but the future use of these fibers is unlimited.

  Adding fiber can alter texture - sometimes an advantage, sometimes not. Fiber can help a product retain its integrity during processing, or give integrity to engineered foods. The size and shape of the fiber particle often influences its functionality.

  Phytosterols and phytostanols. Phytosterols are plant-based components currently being evaluated for their health benefits. These naturally occurring plant sterols have a chemical structure similar to that of cholesterol, but are not synthesized by the human body. The most abundant phytosterols are sitosterol and campesterol.

  Phytostanols, the saturated forms of phytosterols, are found in less abundance. The most common phytostanols are sitostanol and campestanol. Research indicates that both phytosterols and phytostanols might lower blood-cholesterol levels. This beneficial effect is thought to be related to the effects of phytosterols on absorption of dietary and biliary cholesterol in the gut.

  Incorporation of these plant sterols into foods began when a process was identified that allowed these products to be esterified and solubilized into foods, while minimally changing their taste and appearance. Fort Washington, PA-based McNeil Consumer Healthcare's Benecol® products and Englewood Cliffs, NJ-based Lipton's Take Control™ foods recently hit the U.S. market, and have been highly publicized. Not surprisingly, consumers are excited about these phytosterol-containing products, which are currently available in the form of margarine and salad dressings, items traditionally relatively high in the saturated fats linked to high cholesterol.

  Omega-3 fatty acids. Omega-3 fatty acids are essential polyunsaturated fatty acids found naturally in the diet. The three main omega-3s are alpha-linolenic acid (ALA), which may provide beneficial effects against certain cancers; eicosapentaenoic acid (EPA); and docosahexaenoic acid (DHA), which helps build infants' brain tissue.

  Omega-3 fatty acids, which appear to help protect against cardiovascular diseases, arthritis, certain cancers and some gastrointestinal disorders, are found mainly in fish and certain nuts and seeds such as flaxseed. Currently, the recommendation from various health organizations is to consume 0.5 to 2.0 grams of omega-3 fatty acids per day. However, the Food and Nutrition Board might begin reviewing the data of omega-3 fatty acids, possibly leading to a formal recommendation in the near future. Last year, the FDA approved menhaden fish oil as a GRAS ingredient, making it a prime candidate for functional foods.

  Soy. "Although the epidemiological data are inconsistent, those studies that show protective effects indicate that as little as one serving (e.g., 8 oz. soy milk, 4 oz. tofu) of soy per day - approximately 30 mg of isoflavones - is associated with a reduced cancer risk," says Mark Messina, Ph.D., Nutrition Matters, Inc., Port Townsend, WA. The main isoflavones found in soy are genistein, daidzein and glycitein.

  Soy's benefits are greater than a reduced risk of cancer, however, and also include a reduction of menopausal symptoms such as hot flashes, osteoporosis and cardiovascular diseases. In fact, the FDA is set to approve a health claim linking consumption of soy protein with a reduced risk of coronary heart disease.

  Soybeans are low in fat and calories and high in fiber. Soy in the form of isolates and concentrates can be added to a range of products, including beverages. Formulating soy into an appealing beverage is not always easy. "Heat and processing may change the flavor profile of the beverage," says Draganchuk. She recommends bringing flavor companies into the early stages of planning, especially if the product is also to be fortified with vitamins, minerals or herbs, and if "specialty" flavors may be required. It's important to remember that a new product can be exceptionally nutritious and healthful, but if it doesn't taste good and isn't pleasing to the palate, it won't succeed.

  Antioxidants. Many nutritive and non-nutritive antioxidants, including vitamins A, C and E, as well as selenium, coenzyme Q10 and other phytochemicals, such as anthocyanins, are being incorporated into functional foods because of their wide range of health benefits. A number of companies are already formulating products with antioxidants - Tropicana's orange juice with vitamins A, E and extra C, for example.

  Antioxidants reduce the damage caused by free radicals, which are compounds with an extra electron. These free radicals can react with, and damage, unsaturated fatty acids, proteins and DNA - which is the basis of one theory of how cancers are formed. However, the oxidative-stress theory proposes that pro-oxidants can form when the body exceeds the antioxidant level necessary to avoid oxidation, resulting in stroke, cancers and heart disease. Research is still underway in this area to determine the minimum and maximum levels of antioxidants that should be consumed daily.

  Probiotics. Friendly bacteria such as Bifidobacterium and Lactobacillus have shown positive effects in improving lactose digestion, reducing cholesterol, reducing vaginal yeast infections, reducing colon cancer, and boosting the immune system. With all of these benefits, it's no wonder that many of the new FOSHU products in Japan this year have been in the yogurt and yogurt-drink category.

  "The physical form of probiotic cultures can be added directly to liquid products as frozen concentrate, or can be used in liquid preparations and in powder and capsules or freeze-dried concentrates," said Lars Peterson, Ph.D., manager, special corporate projects and probiotics, department of technology, Chr. Hansen, Inc., Milwaukee. It's important to select the proper processing choice for your product. For example, "freezing lowers temperature, so it slows the destruction of metabolite x and the product has a longer shelf life; however, it can also kill useful probiotics," says Labuza.

The future of functional foods
  By 2005, there will be an estimated 30% increase in major health problems, due in part to aging baby-boomers. Even children are a rich market, however, with childhood obesity becoming a nationwide problem. Although no single functional food can erase the effects of a lousy diet, foods with genuine health benefits could make life a little easier for the many people struggling to eat right. Functional foods deliver the positive message of "eating well," rather than the old messages of "reduce" and "avoid."

  It's important for companies to remember that people will not give up taste and flavor for health - especially for long-term use. "Another aspect to flavoring fortified and functional foods is that consumers sometimes expect them to have a certain level of off-taste or they may not feel they are getting the real thing. Judgement and sensory testing are important to determine the optimal balance," says Draganchuk. She adds that flavor is not a cure-all. It can add a lot of expense to the product cost, as well as accentuate off-notes if over-used - it's important to mask off notes before flavor is added.

  Regulatory standards and rulings about safety and efficacy will have to become standardized. "We are willing to work with the FDA to provide accurate science and good products. These products are beginning to show benefits, and the more we can do to support the FDA in food safety, we should do so - it should be complementary," comments Wilson.

  To successfully introduce these products, partnering of companies will likely become even more commonplace. Carol Pekar, a partner in Poutray, Pekar, Stella, Inc., Norwalk, CT, identified some of the advantages to partnering at the "Functional Foods: Strategies for the Food Industry" conference. "There's shared risk, more flexibility, improved cost control, in-depth knowledge of regulatory and clinical issues, more responsiveness to consumers' needs and most importantly, access to world-class technology and applications assistance when partnering," she observed.

  The worldwide opportunity for future growth and development of new functional foods is tremendous. Advances in medical research, coupled with continuous new food-technology developments, will provide many opportunities for manufacturers to produce cutting-edge functional foods that address the needs of the health-conscious consumer.


  Andrea D. Platzman, a registered dietitian, is a consultant to the food industry and regularly writes for nutrition publications. She earned a master's degree in nutrition from New York University, and has a culinary and business background.


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